The draft guidance describes FDA’s recommendation that applicants submit summary-level clinical-site datasets in a standardized electronic format. This guidance generally applies to submissions of summary-level clinical-site datasets for new drug applications (NDAs), biologics licensing applications (BLAs), and NDA and BLA supplemental applications containing new clinical-study reports that are submitted to FDA’s Center for Drug Evaluation and Research (CDER). The purpose of the guidance is to assist applicants in the submission of a clinical dataset that describes and summarizes the characteristics and outcomes of clinical investigations at the level of the individual study site (summary-level clinical-site data). The summary-level clinical-site dataset is intended to facilitate the use of a risk-based approach for the timely identification of clinical investigator sites for on-site inspection by CDER during the review of marketing applications. The guidance refers to a number of technical specification documents and other resources. These technical specification documents and resources are available online to make them more accessible to applicants.